The present invention relates generally to methods and apparatus for valving bodily fluids, such as urine, and particularly to urethral drainage catheters for controlling discharge of fluid from the bladder and more and particularly to a device which is completely implanted within the bladder and adjacent portions of the urethra.
1. Field of the Invention
Urinary incontinence is a serious and long-recognized problem in the medical field, and much effort has been directed to providing devices for handling the problem. The number of patents granted in this field are evidence of such efforts.
Urinary incontinence is the inability to voluntarily control the elimination function of the bladder. This problem can result from numerous causes, including old age, disease, trauma, or some form of neurological dysfunction, and the problem is generally incurable. The patient suffering from urinary incontinence may experience embarrassment, discomfort, and loss of self-esteem. In addition, normal human activity may be severely limited.
Attempts to alleviate this problem have generally involved either external or external/internal devices. Examples of external devices are adult diapers and urine alarms. External/internal devices such as urinary catheters have also been studied. However, such catheters have a limited indwelling life because of the likely onset of serious urethral infections. The operation of such devices is also severely complicated by the very limited diameter of the urethra. These and other complications have made elusive the search for an indwelling urine control device that achieves comfortable, convenient and relatively "normal" bladder control for the incontinent patient.
2. Description of the Related Art
Numerous devices have been developed to facilitate the controlled discharge of the urinary bladder, one of the most common being a urethral catheter extending from the bladder, through the entire urethral tract, to the exterior of the body. The catheter is ordinarily inserted into the bladder and retained in position by inflatable cuffs or balloons. A drainage passageway extends the length of the catheter, allowing urine to flow from the bladder to the atmosphere. The drainage passageway may, alternatively, be connected to a collector bag or include a shut-off valve for controlling the passage of urine. U.S. Pat. Nos. 3,642,004 ("Osthagen"), 3,811,450 ("Lord"), and 4,022,216 ("Stevens") are representative of such devices.
The Osthagen, Lord, and Stevens devices have numerous well-known disadvantages, not the least of which is susceptibility to infection. The protruding catheter provides an ideal path for migration of bacteria into the bladder, possibly resulting in extreme complications. Further, the use of collector bags can be both uncomfortable and embarrassing, adversely affecting the wearer's psyche. Finally, use of devices which extend beyond the urethra restricts or prohibits normal activities.
Another approach to the problem of controlling urinary incontinence has been to provide a means for constricting the urethra to block the flow of urine, with the capability of selectively releasing the constriction to allow voiding of the bladder. Such devices are described in U.S. Pat. Nos. 3,939,821 ("Roth") and 3,750.,194 ("Summers"). The most common problems associated with the use of a constricting device are impaired circulation, edema, and urethral diverticulum.
Still other methods have been developed to control urinary incontinence by using completely indwelling devices. U.S. Pat. Nos. 3,768,102 ("Kwan-Gett") and 3,797,478 ("Walsh") describe devices which rely on normal voiding pressure being exerted by the wearer to overcome a threshold resistance and start the flow of urine. The devices automatically return to a closed state upon evacuation of the bladder. Another such device is shown in application Ser. No. 6-550,040, filed by Stephen B. Leighton ("Leighton").
Other indwelling urethral catheters have incorporated valves which are actuated by external forces. U.S. Pat. No. 3,812,841 to Isaacson ("Isaacson") shows a urethral valve which is implanted in the urethra at its point of entry into the bladder. Inflatable collars hold the structure in place while a valve internal to the device prevents the flow of urine through the drainage canal. The valve is magnetic in nature and responds to a magnetic field generated at the exterior of the body. The external field causes the valve to open, thus allowing the bladder to be voided through the urethra, and removal of the field then allows the valve to return to a closed position. The numerous mechanical parts of the Isaacson valve increase the possibility of malfunction of the unit and consequential repair or replacement. Further, the physical size and relative inability of the catheter to collapse, being of "slightly flexible deformable plastic" and sufficiently large to obstruct the urethra near the bladder, present extreme difficulties in insertion and removal.
U.S. Pat. Nos. 4,350,161 and 4,432,757, both to Davis, Jr. ("Davis") show an indwelling urethral catheter used by males which is secured in the bladder by a Foley-type balloon and which extends the length of the urethra to the penile urethra. A valve is mounted in the distal end of the catheter and is normally biased to a closed position. The valve is actuable to an open position by external hand manipulation of the penis. Although the Davis catheter does not extend to the penile meatus, it occupies a significant portion of the penile urethra. Such a position reduces the length of urethra which is subject to the normal flushing of urine and may invite migratory infections. Further, location of the distal end of the catheter and the valve in the penile urethra may result in considerable discomfort upon expansion and contraction of the penis, as upon erection. Finally, as in Isaacson, the rigid valve structure can be a source of considerable discomfort and trauma both in insertion and removal and during normal usage.
One object of the present invention is to overcome many of the above-mentioned drawbacks by providing a manually actuated urinary continence device which is completely indwelling within the urinary tract, thereby reducing the possibility of infection associated with many of the prior devices.